ulcerative colitis – india drug forecast and market ... · in 2012, globaldata estimated that...
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REFERENCE CODE GDHC223CFR| PUBLICATION DATE FEBRUARY 2014
ULCERATIVE COLITIS – INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
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ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Sales for Ulcerative Colitis in India
In 2012, GlobalData estimated that India Ulcerative
Colitis (UC) market reached $94.9 million. By the
end of the forecast period, in 2022, sales across
India will grow steadily to reach $261.2 million,
representing a Compound Annual Growth Rate
(CAGR) of 10.7% over the 10-year timeframe.
Major growth drivers in the UC market over the
forecast period include:
Continued investment in the national
healthcare system and services
Sizeable UC patient population that will
increase over the coming decade
Conversely, major barriers to the growth of the UC
market include:
Loose intellectual property policies present a
major challenge for developers with novel
drugs.
Limited access to and the high-price point of
UC therapies, coupled with many Indians’
belief in traditional medicine, negatively
impacts brand sales.
Downward pricing pressure limits drug sales
growth.
Figure below illustrates India Ulcerative Colitis
sales during the 10-year forecast period.
Sales for Ulcerative Colitis in India by Drug Class, 2012–2022
26.72%
0.23%1.04%
72.00%
2012 Total: $94.9m
5-ASAs
Steroids
Purine Analogs
Biologics
10.21%
0.13%0.53%
0.07%
48.96%
40.10%
2022 Total: $261.2m
5-ASAs
Steroids
Purine Analogs
Immunomodulators
Biologics
Biosimilars
Source: GlobalData
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ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
What Do Physicians Think?
Physicians interviewed by GlobalData expressed
doubts about the use of Inflectra (an infliximab
biosimilar) following its approval in Europe in
September 2013.
“I do not comprehend what the EMA based the
label extrapolation upon. I would like to see data
from a clinical trial of Inflectra done on UC patients.
I’m afraid, though, that we [physicians] might
receive pressure to prescribe this biosimilar
treatment because of the healthcare funding cuts”
[EU] key opinion leader, October, 2013
The physicians also underscored the need for a
curative treatment for UC.
“Essentially, there is no adequate treatment for
severe UC patients. AZA [azathioprine] has an
unpredictable array of adverse effects and no
guaranteed efficacy. The biologics only work in
40% of the severe UC patients, and in most cases,
they are underdosed. We need a curative
treatment.”
[EU] key opinion leader, October 2013
Some KOLs expressed the opinion that UC
patients should be referred to a specialist before
they develop bloody diarrhea, as well as the desire
for companies to develop disease severity
prediction tests, which could allow for the earlier
detection of UC.
“Patients usually go to their primary care
physicians and complain about chronic diarrhea,
some sort of uveitis, poor quality of life, etcetera. If
colonoscopy is considered necessary, and a heavy
colonic inflammatory burden is observed, then the
patient undergoes regular monitoring. This doesn’t
happen with everyone, though, and in 90% of the
cases, UC is diagnosed upon the presence of
bloody diarrhea. But, I think we can catch it sooner.
We need a [disease] severity prediction test.”
[US] key opinion leader, November, 2013
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ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
The physicians also commented on the clinical
positioning that they would choose for Takeda’s
pipeline therapy, Entyvio.
“I think if vedolizumab is as good as it looks, it will
be [a] first- or second-line treatment in place of
azathioprine. If you have a UC patient relapsing
frequently, despite the use of mesalazine,
vedolizumab will be an ideal candidate. I regard it
as safer than azathioprine and more effective [for
UC]. [However,] I would carry on using anti-TNFs
for the treatment of CD.”
[EU] key opinion leader, September 2013
The physicians also shared their thoughts on the
high risk of colorectal cancer in inflammatory bowel
disease (IBD) sufferers, which includes those with
UC.
“Colorectal cancer is a huge risk in UC
patients….Pharmaceutical intervention is not
designed to prevent this risk. The use of
immunosuppressants does not help.”
[EU] key opinion leader, September 2013
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Table of Contents
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
1 Table of Contents
1 Table of Contents ....................................................................................................................... 5
1.1 List of Tables ...................................................................................................................... 9
1.2 List of Figures ................................................................................................................... 10
2 Introduction ............................................................................................................................... 11
2.1 Catalyst ............................................................................................................................. 11
2.2 Related Reports ................................................................................................................ 11
2.3 Upcoming Related Reports ............................................................................................... 13
3 Disease Overview ..................................................................................................................... 14
3.1 Etiology and Pathophysiology ........................................................................................... 14
3.1.1 Etiology ......................................................................................................................... 14
3.1.2 Pathophysiology ............................................................................................................ 16
3.2 Symptoms ......................................................................................................................... 18
3.2.1 Quality of Life ................................................................................................................ 18
4 Disease Management ............................................................................................................... 20
4.1 Diagnosis and Treatment Overview .................................................................................. 20
4.1.1 Diagnosis ...................................................................................................................... 20
4.1.2 Treatment Guidelines and Leading Prescribed Drugs ................................................... 24
4.1.3 Clinical Practice ............................................................................................................. 25
4.2 India .................................................................................................................................. 29
5 Competitive Assessment .......................................................................................................... 31
5.1 Overview ........................................................................................................................... 31
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Table of Contents
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
5.2 Strategic Competitor Assessment ..................................................................................... 32
5.3 Product Profiles – Major Brands ........................................................................................ 33
5.3.1 Remicade (infliximab) .................................................................................................... 33
5.3.2 Apriso (mesalamine) ..................................................................................................... 40
5.3.3 Asacol HD (mesalamine) ............................................................................................... 44
5.3.4 Pentasa (mesalamine) .................................................................................................. 48
5.3.5 Other Drug Classes Used in the Treatment of UC ......................................................... 51
5.4 Biosimilars ........................................................................................................................ 52
5.4.1 Introduction ................................................................................................................... 52
5.4.2 Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases .................... 53
5.4.3 Biosimilars in the Immunology Community .................................................................... 53
5.4.4 By the Numbers: Biosimilars in Development ................................................................ 54
5.4.5 The Impact of Biosimilars Will be Felt Throughout the Pharmaceutical Industry ............ 57
6 Opportunity and Unmet Need ................................................................................................... 58
6.1 Overview ........................................................................................................................... 58
6.2 Unmet Needs .................................................................................................................... 59
6.2.1 Curative Therapy for Severe UC Patients ...................................................................... 59
6.2.2 Diagnostic Markers for Disease Severity ....................................................................... 59
6.2.3 Personalized Therapy ................................................................................................... 59
6.2.4 A Replacement for Steroids ........................................................................................... 60
6.2.5 Novel Oral Drug Formulations ....................................................................................... 61
6.2.6 Preventative Medicine for Lowering the Associated Colorectal Cancer Risk ................. 62
6.2.7 Improved Management of Infectious Adverse Events .................................................... 62
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Table of Contents
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
6.3 Unmet Needs Gap Analysis .............................................................................................. 63
6.4 Disease Severity and Colorectal Cancer Biomarker-Based Prognostic Tools.................... 64
6.5 Predictors of Medically-Refractory Disease ....................................................................... 65
7 Pipeline Assessment................................................................................................................. 66
7.1 Overview ........................................................................................................................... 66
7.2 Promising Drugs in Clinical Development .......................................................................... 66
8 Market Outlook ......................................................................................................................... 68
8.1 India .................................................................................................................................. 68
8.1.1 Forecast ........................................................................................................................ 68
8.1.2 Key Events .................................................................................................................... 72
8.1.3 Drivers and Barriers ...................................................................................................... 72
9 Appendix................................................................................................................................... 75
9.1 Bibliography ...................................................................................................................... 75
9.2 Abbreviations .................................................................................................................... 79
9.3 Methodology ..................................................................................................................... 83
9.4 Forecasting Methodology .................................................................................................. 83
9.4.1 Diagnosed UC Patients ................................................................................................. 83
9.4.2 Percent Drug-Treated Patients ...................................................................................... 84
9.4.3 Drugs Included in Each Therapeutic Class .................................................................... 84
9.4.4 Launch and Patent Expiry Dates ................................................................................... 84
9.4.5 General Pricing Assumptions ........................................................................................ 85
9.4.6 Individual Drug Assumptions ......................................................................................... 85
9.4.7 Generic Erosion ............................................................................................................ 86
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Table of Contents
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
9.5 Physicians and Specialists Included in This Study ............................................................ 87
9.6 Primary Research – Prescriber Survey ............................................................................. 89
9.7 About the Authors ............................................................................................................. 90
9.7.1 Author ........................................................................................................................... 90
9.7.2 Global Head of Healthcare ............................................................................................ 91
9.8 About GlobalData .............................................................................................................. 92
9.9 Disclaimer ......................................................................................................................... 92
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Table of Contents
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
1.1 List of Tables
Table 1: Genetic Factors That Confer a Predisposition to UC ......................................................................... 16
Table 2: Typical Symptoms of UC .................................................................................................................. 18
Table 3: Truelove and Witts UC Severity Index .............................................................................................. 22
Table 4: UCDAI ............................................................................................................................................. 23
Table 5: Treatment Guidelines for UC Used in the 10MM ............................................................................... 24
Table 6: Most Commonly Prescribed Drugs for UC by Class in the 10MM, 2013 ............................................ 25
Table 7: UC Management Country Profile – India .......................................................................................... 30
Table 8: Leading Treatments for UC, 2014..................................................................................................... 33
Table 9: Product Profile – Remicade .............................................................................................................. 35
Table 10: Remicade SWOT Analysis, 2014.................................................................................................... 39
Table 11: Product Profile – Apriso .................................................................................................................. 41
Table 12: Apriso SWOT Analysis, 2014 ......................................................................................................... 43
Table 13: Product Profile – Asacol HD ........................................................................................................... 45
Table 14: Asacol HD SWOT Analysis, 2014 ................................................................................................... 48
Table 15: Product Profile – Pentasa ............................................................................................................... 49
Table 16: Pentasa SWOT Analysis, 2014 ...................................................................................................... 51
Table 17: Summary of Other Immunomodulators for UC, 2013 ...................................................................... 52
Table 18: Biosimilars Pipeline, 2013 .............................................................................................................. 55
Table 19: Overall Unmet Needs – Current Level of Attainment ....................................................................... 58
Table 20: Corticosteroid Long-Term Side Effects ........................................................................................... 61
Table 21: Clinical Unmet Needs in UC – Gap Analysis, 2013 ......................................................................... 64
Table 22: Prognostic Markers in UC............................................................................................................... 65
Table 23: UC – Pre-Registration and Phase III Pipeline, 2014 ........................................................................ 66
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Table of Contents
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
Table 24: Comparison of Therapeutic Classes in Development for UC, 2014 ................................................. 67
Table 25: Sales Forecasts ($) for UC in India, 2012–2022.............................................................................. 69
Table 26: Key Events Impacting Sales for UC in India, 2012–2022 ................................................................ 72
Table 27: UC Market in India – Drivers and Barriers, 2012–2022 ................................................................... 72
Table 28: Key launches for Ulcerative Colitis , 2012-2022 ......................................................................... 84
Table 29: Key Patent Expiries ........................................................................................................................ 85
Table 30: Annual Cost of Therapy for 5-ASAs ($) ...................................................................................... 86
Table 31: Physicians Surveyed, By Country ................................................................................................... 89
1.2 List of Figures
Figure 1: Cellular Mechanisms Involved in the Pathogenesis of UC ............................................................... 17
Figure 2: UC Disease Management Flowchart ............................................................................................... 28
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents UC, 2012–2022 ........................................ 67
Figure 4: Sales for UC in India by Drug Class, 2012–2022 ............................................................................. 71
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ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
Introduction
2 Introduction
2.1 Catalyst
The catalysts for this report are to:
Assess the future of the currently marketed tumor necrosis factor (TNF)-blocking biologics,
Remicade (infliximab) and Humira (adalimumab), following their loss of patent protection, the
launch of new products, and the introduction of biosimilars into the market.
Examine the impact that Entyvio’s (vedolizumab’s) estimated launch in 2014 will have on the
management of ulcerative colitis (UC) and the competitive landscape in terms of market value.
Evaluate the significance of the late-stage pipeline products and how their launch will shape
the future treatment landscape in UC.
Identify the remaining unmet needs in UC and highlight untapped opportunities.
The launch of new biologic drugs will increase treatment options, improve disease management,
and drive growth in the UC market. Although the need for safe and effective new treatments, let
alone a curative drug, is paramount for patients with UC, the products that are currently in the
pipeline are expected to face challenges in gaining patient share following their entry into the UC
market. These new entrants will undergo pricing and reimbursement pressures and will also face
fierce competition from infliximab and adalimumab biosimilars.
2.2 Related Reports
GlobalData (2013). PharmaPoint: Psoriasis – Global Drug Forecast and Market Analysis to
2022, May 2013, GDHC48PIDR
GlobalData (2013). PharmaPoint: Rheumatoid Arthritis – Global Drug Forecast and Market
Analysis Event-Driven Update, July 2013, GDHC60PIDR
GlobalData (2014). PharmaPoint: Ulcerative Colitis – Global Drug Forecast and Market
Analysis to 2022, February 2014, GDHC80PIDR
GlobalData (2014). Ulcerative Colitis – US Drug Forecast and Market Analysis to 2022,
February 2014, GDHC218CFR
Ulcerative Colitis - India Drug Forecast and Market Analysis to 2022 12 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
Introduction
GlobalData (2014). Ulcerative Colitis – 5EU Drug Forecast and Market Analysis to 2022,
February 2014, GDHC219CFR
GlobalData (2014). Ulcerative Colitis – Japan Drug Forecast and Market Analysis to 2022,
February 2014, GDHC220CFR
GlobalData (2014). Ulcerative Colitis – Canada Drug Forecast and Market Analysis to 2022,
February 2014, GDHC221CFR
GlobalData (2014). Ulcerative Colitis – China Drug Forecast and Market Analysis to 2022,
February 2014, GDHC222CFR
GlobalData (2014). Entyvio (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC342DFR
GlobalData (2014). Xeljanz (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC343DFR
GlobalData (2014). Kappaproct (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC344DFR
GlobalData (2014). Remicade (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC345DFR
GlobalData (2014). Humira (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC346DFR
GlobalData (2014). Simponi (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC347DFR
GlobalData (2014). Apriso (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC348DFR
GlobalData (2014). Asacol HD (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC349DFR
GlobalData (2014). Lialda (Ulcerative Colitis) - Forecast and Market Analysis to 2022, February
2014, GDHC350DFR
Ulcerative Colitis - India Drug Forecast and Market Analysis to 2022 13 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
Introduction
GlobalData (2014). Pentasa (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC351DFR
GlobalData (2014). Colazal & Giazo (Ulcerative Colitis) - Forecast and Market Analysis to
2022, February 2014, GDHC352DFR
GlobalData (2014). sfRowasa (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC353DFR
GlobalData (2014). Uceris (Ulcerative Colitis) - Forecast and Market Analysis to 2022,
February 2014, GDHC354DFR
GlobalData (2014). Ulcerative Colitis - Current and Future Players, February 2014,
GDHC1029FPR
2.3 Upcoming Related Reports
GlobalData (2014). PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market
Analysis to 2022, January 2014, GDHC77PIDR
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Appendix
ULCERATIVE COLITIS - INDIA DRUG FORECAST AND MARKET ANALYSIS TO 2022
9.8 About GlobalData
GlobalData is a leading global provider of business intelligence in the healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports, and
forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,
Singapore, and Australia.
9.9 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior
permission of the publisher, GlobalData.